An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
Exelixis’ CABOMETYX Showed Positive Results Treating NET in Recent Trial
On May 30, Exelixis, Inc., announced results from a subgroup analysis of the phase 3 CABINET pivotal trial, which showed that CABOMETYX® (cabozantinib) provided significant improvements in progression-free survival (PFS) versus placebo in patients with previously treated advanced neuroendocrine tumors (NET) regardless of functional status.
These data were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting to be held from May 29 – June 2 in Chicago.
“Understanding the effects of oral pathway inhibitors in patients with both functional and non-functional NET is critical in informing appropriate treatment-sequencing decisions,” said Nikolaos A. Trikalinos, MD, associate professor of medicine, Washington University School of Medicine and Siteman Cancer Center. “Patients with hormone-producing tumors may require approaches that not only control tumor growth but also help mitigate challenging hormone-related symptoms. It is encouraging that our results reinforce cabozantinib as a meaningful treatment option for patients with advanced NET regardless of functional status. In both non-functional and functional NET, cabozantinib delivered substantial improvements in disease control compared to placebo, with median progression-free survival increasing threefold in non-functional NET and more than doubling in functional NET compared to placebo.”
In the phase 3 CABINET study, patients with locally advanced or metastatic pancreatic NET (pNET) or extra-pancreatic NET (epNET) were randomized 2:1 in separate cohorts to receive CABOMETYX 60 mg daily versus placebo. Of the 298 patients enrolled in both cohorts, 179 had non-functional NET (cabozantinib, n=123; placebo, n=56), 74 had functional (i.e., hormone-releasing) NET (cabozantinib, n=47; placebo, n=27); and 45 had unknown functional status (cabozantinib, n=28; placebo, n=17).
These subgroup results show cabozantinib demonstrated improvements in PFS regardless of functional status. In patients with non-functional NET, the hazard ratio (HR) was 0.26 (95% confidence interval [CI]: 0.17–0.41; p<0.001); median PFS was 9.4 months with cabozantinib (95% CI: 8.5–13.8) versus 3.1 months with placebo (95% CI: 2.9–5.7). In patients with functional NET, the HR was 0.40 (95% CI: 0.20–0.82; p=0.012); median PFS was 12.7 months (95% CI: 8.4–17.9) with cabozantinib versus 5.4 months with placebo (95% CI: 3.7–not estimable).
“Following last year’s U.S. and EU approvals of CABOMETYX for the treatment of previously treated advanced NET, these subgroup findings from the CABINET trial reinforce its ability to delay disease progression for a broad and heterogenous population of these patients,” said Dana T. Aftab, PhD, executive vice president, Research & Development, Exelixis. “CABOMETYX is now the leading oral therapy for previously treated advanced NET, helping to address a significant unmet need for patients who have limited options. We are committed to further improving standards of care for this disease and look forward to learning about the potential of zanzalintinib, our investigational oral kinase inhibitor, to improve outcomes in an early line of treatment compared to everolimus in our ongoing STELLAR-311 pivotal trial.”
The safety profile of CABOMETYX observed in patients with functional and non-functional NET was consistent with its known safety profile; no new safety signals were identified. The most frequent grade 3/4 adverse events with cabozantinib in patients with functional NET were hypertension (21%) and diarrhea (9%); in non-functional NET, they were hypertension (21%) and fatigue (18%).
Rezolute Announces Positive Interim Data for its Phase 3 upLIFT Study of Ersodetug in Tumor Hyperinsulinism
On June 2, Rezolute, Inc., a late-stage ultra-rare disease company focused on treating refractory hypoglycemia caused by a congenital or any acquired form of hyperinsulinism (HI), provided an interim update on its ongoing open-label Phase 3 study (upLIFT) of ersodetug in tumor HI.
With eight participants enrolled in upLIFT to date, comprising both insulinoma and non-islet cell tumor hypoglycemia, the company is midway through enrollment of the planned study sample size of 16 participants.
Of the eight participants enrolled, six have already met the responder criterion for the study’s primary endpoint, which is the number of participants achieving at least a 50 percent reduction from baseline in intravenous glucose requirements (glucose infusion rate; GIR) within the eight-week pivotal treatment phase. Each of these six participants also achieved a complete discontinuation of intravenous glucose requirements with the administration of ersodetug.
One of the eight enrolled participants withdrew study consent and discontinued ersodetug and all other non-palliative therapies prior to completion of the pivotal treatment phase. This patient had Stage 4 metastatic colon cancer and a poor Eastern Cooperative Oncology Group performance status (ECOG 4). The participant elected to be discharged from the hospital to receive hospice care at home, where they died one week later due to cancer progression. The reduction and eventual discontinuation of intravenous glucose were undertaken in the setting of hospice transition, so the participant is being counted as a non-responder for purposes of assessing the primary endpoint.
The eighth participant was recently enrolled and is still dosing in the pivotal phase of the study. All participants that have completed the 8-week pivotal treatment period have elected to continue into the open-label extension, with a cumulative treatment duration of up to 6 months. Ersodetug has been well-tolerated in the pivotal and extension phases of the study, with no drug-related adverse events or other safety findings reported to date.
“We are very excited by the interim observations from the upLIFT study as they largely mirror what we previously observed and reported from an initial case series of patients from our expanded access program for compassionate use,” said Brian Roberts, MD, chief medical officer of Rezolute. “These results reveal the clinically impactful hypoglycemia-correcting activity of ersodetug in an unbiased GIR assessment in patients with HI caused by varying tumor types. This further highlights the aberrant outcome from the recently completed randomized, placebo-controlled, Phase 3 sunRIZE study in pediatric congenital HI, where we believe that self-monitored glycemic measures were confounded by divergent caretaker behaviors stemming from functional unblinding to treatment status by real-time glucose monitoring. Importantly, these findings continue to support the potential for ersodetug to be a universal treatment option for patients with serious and refractory hypoglycemia caused by congenital and a variety of acquired forms of hyperinsulinism, including tumor HI and following bariatric and non-bariatric gastrointestinal surgeries. We look forward to announcing topline results of the fully enrolled upLIFT study in tumor HI in the second half of 2026, as well as continuing our engagement with FDA to determine the path forward for the congenital HI indication.”
Glooko Introduces the First and Only Pump Settings EHR Integration to Bring Insulin Pump Data Directly Into Clinical Workflows
On June 5, Glooko, Inc., a global digital health company focused on helping clinicians address the growing challenges of glycemic safety and diabetes management across the care continuum, announced the launch of its Insulin Pump Settings Electronic Health Record (EHR) Integration, a new and first-of-its-kind capability in its latest software release that visualizes critical insulin pump configuration data directly into the clinical workflow.
For clinics caring for people with diabetes using insulin pump therapy, visibility of pump settings provides essential clinical context. Basal schedules, insulin-to-carbohydrate ratios, insulin sensitivity factors, blood glucose target ranges, closed-loop status and active insulin time all help care teams understand how insulin is being delivered and whether therapy adjustments may be needed. Historically, much of this information has lived outside the EHR isolated in external software, PDFs or screenshots, requiring clinicians and staff to toggle between systems, manually transcribe data or copy and paste pump settings into visit notes. Glooko’s new Pump Settings EHR Integration is designed to replace that fragmented workflow with structured, discrete pump settings data visualized in EHR flowsheets that can be pulled automatically into clinical documentation using SmartText-style workflows, depending on EHR configuration.
“Pump settings are the source of truth for how an insulin pump is delivering therapy; however, traditional documentation requires manual transcription of up to 24 different data points into the EHR,” said Mark Clements, MD, PhD, chief medical and strategy officer at Glooko. “When clinicians can see settings such as basal rates, insulin-to-carbohydrate ratios, correction factors, active insulin time and closed-loop status in the same workflow as glucose data and the patient note, the visit becomes less about finding and transcribing information and more about acting on it. This integration, which is unique to Glooko, gives care teams a more complete view of insulin therapy today and creates the structured data foundation for more advanced clinical decision support in the future—where discrete pump settings, glucose trends and other diabetes data can work together to surface more timely, actionable insights. By reducing reliance on incomplete, stale or manually transcribed information, Glooko is helping clinics make therapy adjustments with greater context, consistency and confidence.”
While EHRs remain the system of record, native EHR workflows often depend on the data already available inside the chart. Insulin pump settings, however, are generated and updated across a broad and evolving ecosystem of diabetes devices. Glooko adds a specialized, device-agnostic diabetes data layer that helps normalize pump data across manufacturers and deliver it back into the EHR as usable clinical context. The result is another intuitive management layer for clinics, specifically device data, EHR documentation, and diabetes care decisions working together in the workflow clinicians already use.
“For diabetes clinics and health systems, integrating insulin pump settings directly into the EHR has been a long-desired functionality to eliminate a major source of administrative inefficiency,” said Yaa Kumah-Crystal, MD, MPH, MS, associate professor of biomedical informatics and pediatric endocrinology at Vanderbilt University Medical Center (VUMC). “By removing the tedium of manual input from device readouts, the integrated process will improve data accuracy and lead to more consistent documentation, resulting in happier providers. This ultimately frees up the care team, including clinicians, nurses, and educators, to refocus their attention on the patient in front of them. For patients, this means smoother clinic visits with more directly accessible data to support the shared decision-making process. Holistically, access to this granular data now empowers health systems to track diabetes pump management parameters more precisely and advance targeted quality improvement and population health initiatives.”
This latest Integration strengthens Glooko’s overall EHR integration capabilities and builds on the company’s commitment to connect device data, clinical workflows and patient engagement in a single, intuitive diabetes management platform. Glooko currently supports the centralization of diabetes data from more than 200 diabetes and health monitoring devices and integrates with leading EHR systems to help reduce platform switching and streamline care workflows.
This capability will be launched as part of the Glooko Web 26.2 and Mobile 16.16 product release the week of June 8, which also includes new features to enable population health, and efficient patient management experiences. Availability may vary by EHR configuration, device compatibility and market. All therapy decisions should be made by healthcare professionals using their clinical judgment and available patient information.
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